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Effectiveness of Circular Muscle Exercise (Paula Method) Versus Kegel Exercise for Urinary Stress Incontinence

Primary Purpose

Urinary Stress Incontinence (SI)

Status
Completed
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
circular muscle exercises versus pelvic floor exercises
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Stress Incontinence (SI) focused on measuring Urinary stress incontinence, Randomized trial, circular muscle training, pelvic floor training, bioequivalence

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:ambulatory women, aged 20-65, living in Jerusalem area, able to understand instruction in Hebrew or English, suffering from urinary stress incontinence with a positive Pad test of at least 1 gm - Exclusion Criteria:pregnant,within 12 weeks of delivery,6 weeks since abortion,breastfeeding, illnesses which limit physical activity (cardiac, respiratory, psychiatric and neurological), Pad test < 1gm,pelvic surgery within last 6 months, genital prolapse Grade 3 or higher, previous surgery for urinary incontinence, previous pelvic radiation therapy -

Sites / Locations

  • Dr. Ora Paltiel

Outcomes

Primary Outcome Measures

Mean change in grams of urinary leakage as measured by Pad test

Secondary Outcome Measures

Quality of life as measured by IQOL scale, sexuality as measured by questionnaire, subjective assessment of SI and general health

Full Information

First Posted
September 12, 2005
Last Updated
November 6, 2006
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00197314
Brief Title
Effectiveness of Circular Muscle Exercise (Paula Method) Versus Kegel Exercise for Urinary Stress Incontinence
Official Title
A Randomized Controlled Trial of Circular Muscle Exercises (Paula Method) vs. Pelvic Floor Training (Kegel Exercises) for Urinary Stress Incontinence in Women
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
June 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

Brief Summary
This is a randomized controlled trial comparing two methods of exercise for the treatment of stress incontinence ( loss of urine after physical exertion) in women. We are comparing the Paula method of circular muscle exercise, in which circular muscles controlling sphincters of the body (such as the eyes, mouth and rectum) are exercised, with pelvic floor training (Kegel exercises) in women in the community. The study hypothesis is that the effectiveness of circular muscle exercises is equivalent to pelvic floor training among women with this disorder.
Detailed Description
Background: Urinary stress incontinence(SI) is defined as involuntary urinary loss which appears during increased intra-abdominal pressure which can be measured objectively. It is an important social and hygienic problem. Its prevalence varies fron 12-55% depending on age, and geography. The economic costs of this condition were estimated to reach 24 billion dollars in the US in 1995. The objectives of this study are to evaluate two non-invasive methods of treatment of stress incontinence. Methods: 200 women who chosen from the community and suffering from SI will enter the study and will be randomized to one of two arms. The first arm is the Paula method of circular muscle exercises: these women will receive private lessons from a registered Paula instructor. The system is based on activating circular muscles in the body. The second arm will receive instruction in pelvic floor muscle training by a physiotherapist. The clinical trial will compare the efficacy of the methods for the treatment of SI. The candidates for inclusion in the trial will undergo a gynecological exam and a "Pad Test". The efficacy will be measured in terms of changes in the Pad test (quantity of urinary leakage) and subjective reports of the participants on leakage, quality of life and sexual function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Stress Incontinence (SI)
Keywords
Urinary stress incontinence, Randomized trial, circular muscle training, pelvic floor training, bioequivalence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
200 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
circular muscle exercises versus pelvic floor exercises
Primary Outcome Measure Information:
Title
Mean change in grams of urinary leakage as measured by Pad test
Secondary Outcome Measure Information:
Title
Quality of life as measured by IQOL scale, sexuality as measured by questionnaire, subjective assessment of SI and general health

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:ambulatory women, aged 20-65, living in Jerusalem area, able to understand instruction in Hebrew or English, suffering from urinary stress incontinence with a positive Pad test of at least 1 gm - Exclusion Criteria:pregnant,within 12 weeks of delivery,6 weeks since abortion,breastfeeding, illnesses which limit physical activity (cardiac, respiratory, psychiatric and neurological), Pad test < 1gm,pelvic surgery within last 6 months, genital prolapse Grade 3 or higher, previous surgery for urinary incontinence, previous pelvic radiation therapy -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ora B Paltiel, MD
Organizational Affiliation
Hadassah University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dr. Ora Paltiel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel

12. IPD Sharing Statement

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Effectiveness of Circular Muscle Exercise (Paula Method) Versus Kegel Exercise for Urinary Stress Incontinence

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